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Watering of the Eyes Following Uneventful Phacoemulsification Cataract Surgery

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05683613
Collaborator
(none)
50
Enrollment
7.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

An observational study aiming to assess the incidence and possible causes of post phacoemulsification watery eye.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will be conducted on patients who will undergo cataract extraction at Sohag university hospitals to evaluate the incidence of watery eyes in patients after phacoemulsification by one week , one month and three month.

    • Study Design: observational study.

    • Inclusion Criteria:

    Patients with age-related cataract.

    • Exclusion Criteria:

    1. patients with watering of eyes or ocular surface diseases or watering of the eyes .

    2. patients with previous ocular surgeries.

    3. patients with glaucoma, uveitis, corneal or retinal pathologies.

    • Preoperative Evaluation:
    Each patient will be subjected to the following:

    Detailed history taking and full ophthalmological examination. Fluorescein dye disappearance test. Syringing and probing. Schirmer's test. Tear break up time test. Measurement of punctal diameter by AS-OCT.

    • Operative procedures:

    1. regional anesthesia.

    2. phaco technique : stop and shop.

    3. cumulative dissipated energy (CDE ) &fluid flow.

    • Follow-up regimen: will be as follows:

    1. patients will be examined after surgery on: 1st postoperative week, 1st month, 3rd month.

    2. The following will be recorded for each patient:

    3. symptoms of watery eyes, visual acuity, IOP, slit lamp examination.

    4. dye disappearance test.

    5. Schirmer's test.

    6. tear break up time test.

    7. anterior segment OCT.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Watering of the Eyes Following Uneventful Phacoemulsification Cataract Surgery
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Sep 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Assess the incidence and possible causes of post phacoemulsification watery eye. [Five months]

      Patients are examined preoperatively and postoperatively by flourescein disappearance test, probing and syringing, schirmer's test,tear breakup time test and anterior segment optical coherence tomography to detect incidence and causes of post phacoemulsification watery eye.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with age related cataract.
    Exclusion Criteria:

    • patients with watering of the eyes or ocular surface disease.

    • patients with previous ocular surgeries .

    • patients with glaucoma, uveitis, cornealor retinal pathologies.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Helmy Mahmoud, Resident doctor at ophthalmology department in sohag university hospital, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05683613
    Other Study ID Numbers:
    • AHMahmoud
    First Posted:
    Jan 13, 2023
    Last Update Posted:
    Jan 13, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Jan 13, 2023